Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 3:24 PM
Study NCT ID:
NCT04451759
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI exploration conducted at 7T', 'timeFrame': '2 years', 'description': 'Mapping of MRI parameters of 4 sub-regions of the hypothalamus, in order to determine whether the sensitivity of quantitative T1 to 7T imaging at very high resolution can reveal microstructure variations in the 4 sub-regions of the hypothalamus in patients suffering from obesity or anorexia nervosa compared to a control population without eating disorders.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Disorders']}, 'descriptionModule': {'briefSummary': "Food intake is a motivated behaviour that consists of seeking, selecting and ingesting nutritional resources from the environment. Its main function is therefore, depending on these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical substrates necessary for the proper functioning and need of the body. Thus, in addition to maintaining the body's fat mass level stable, dietary behaviour is part of the energy homeostasis system and is thus regulated and maintained by the central nervous system.\n\nAlthough diet regulation involves several brain regions, the way in which these different regions communicate with each other and influence each other to orchestrate appropriate eating behaviour is not yet fully characterized. Among the structures of this network, the hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a crucial role.\n\nThe investigators propose to use ultra high field (7T) magnetic resonance imaging equiping the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial small structure in food intake networks in order to better understand the impact of these structural and functional disorders observed in patients with anorexia nervosa and obesity compared to a control population without eating behaviour disorders."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No depression (HADS and BECK scores)\n* No contraindication to 7T MRI\n* Subject with with social insurance\n* Subject who has signed the informed consent\n\nFor obese patients\n\n* Body mass index \\> 30kg/m2\n* Body diameter \\< 60cm (compatible with 7T MR scanner tube)\n\nFor anorexic patients\n\n* mental anorexia according to DMS-V\n* Body mass index \\< 17kg/m2\n\nFor healthy controls\n\n* 18.5kg/m2\\<Body mass index \\< 25kg/m2\n* no feeding behavioral disturbance (SCOFF and EAT 26)\n\nExclusion Criteria:\n\n* Pregnant or parturiente woman\n* subject with other neurological or neuropsychiatric diseases\n* subject with addiction'}, 'identificationModule': {'nctId': 'NCT04451759', 'acronym': 'HYPOTHALNET', 'briefTitle': 'Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia', 'orgStudyIdInfo': {'id': '2019-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'healthy controls', 'interventionNames': ['Other: MRI exploration']}, {'type': 'EXPERIMENTAL', 'label': 'Anorexia', 'interventionNames': ['Other: MRI exploration']}, {'type': 'EXPERIMENTAL', 'label': 'Obesity', 'interventionNames': ['Other: MRI exploration']}], 'interventions': [{'name': 'MRI exploration', 'type': 'OTHER', 'description': 'ultra high field (7T) magnetic resonance imaging', 'armGroupLabels': ['Anorexia', 'Obesity', 'healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime Guye, MD', 'role': 'CONTACT', 'email': 'maxime.guye@ap-hm.fr'}], 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Maxime Guye, MD', 'role': 'CONTACT', 'email': 'maxime.guye@ap-hm.fr'}], 'overallOfficials': [{'name': 'Jean Olivier ARNAUD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}